Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT07296094
Eligibility Criteria:
To be eligible, individuals must be:
* English speaking adults between ages 18 and 65
* Diagnosis of DSM5 AUD, severe
* Completion of inpatient withdrawal management (i.e. "detox") for AUD within 90 days of enrollment
* Amenable to attending all psychotherapy and study visits at BWH CCI
* Able to identify an individual who can act as points of contact during the trial
* Have a friend or family member who can bring the participant home after the psilocybin sessions and stay overnight
Individuals with any of the following will be excluded:
* Any personal history of a psychotic disorder (schizophrenia, schizoaffective disorder, brief psychotic disorder, delusional disorder, schizophreniform disorder, substance-induced psychotic disorder or major depression with psychotic features) or any bipolar-spectrum disorder
* Participants with a family history of first-degree relatives with psychotic disorder or bipolar-spectrum disorder
* Participants who have a significant suicide risk as defined by current suicidal ideation (Columbia-Suicide Severity Rating Scale (C-SSRS) score 2 to 5) and/or recent (within the past 6 months) active suicidal ideation (C-SSRS score 4 or 5)
* Participants who have a history of significant or serious adverse reaction to classic psychedelics
* Homicidality within the last six months
* History of DSM5 hallucinogen use disorder
* Positive blood alcohol level at screening
* Need for inpatient withdrawal management for alcohol at the time of screening
* Current DSM5 opioid, cocaine, stimulant or sedative/hypnotic use disorder
* Systolic blood pressure persistently above 165mmHg during screening
* History of hypersensitivity to psilocybin
* Use of psilocybin or other psychedelics with 5-HT2B activity in the prior 12 months
* Significant EKG abnormalities including QTc prolongation defined as \>450 ms for men and women, or a diagnosis or family history of Long QT syndrome.
* History of any cardiac valvulopathy that raises the risk for participation as determined by the cardiology consultant
* History of intracranial mass or bleed, seizure disorder other than alcohol withdrawal seizures, liver cirrhosis, renal failure, obstructive lung disease requiring supplemental oxygen, hyperthyroidism, narrow-angle glaucoma, uncontrolled cardiac arrythmias, heart failure
* History of head trauma, stroke, or myocardial infarction in one year prior to enrollment.
* Expected to require surgical treatment at any point during the trial
* Liver dysfunction with LFTs \> 3x upper normal limit at screening and Total bilirubin \> 2.5x the upper normal limit
* MRI contraindications (other ferromagnetic implants, body weight greater than 550 lbs., etc.)
* Pregnant or breastfeeding
* High risk for adverse emotional or behavioral reaction based on the opinion of the study investigators such as evidence of a personality disorder
* Currently taking medications with serotonergic activity (other than SSRIs/SNRIs); inhibitors of UGT1A9, UGT1A10, MAO, and aldehyde or alcohol dehydrogenase; antipsychotics (e.g., first and second generation); mood stabilizers (e.g., lithium, valproic acid); or significant inhibitors of UGT enzymes that metabolize psilocin
* Selective serotonergic reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors are allowed if participants have been on stable doses of the medication(s) for at least 30 days prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07296094
Study Brief:
Protocol Section:
NCT07296094